Metformin in Pregnant PCOS Women (PregMet)

Norwegian University of Science and Technology

Status and phase: Completed; Phase 3

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT00159536

PregMet

Details and patient eligibility

About

To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.

Enrollment: 257 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-45 years,
• PCOS diagnosis according to Rotterdam criteria
• single, viable, ultrasound verified fetus
• if metformin was used at conception and early pregnancy, at least 7 days of "wash out"

Exclusion criteria

• known liver disease or ALAT > 90 nmol/L
• known renal disease or creatinine > 110 micromol/L
• diabetes mellitus
• alcohol or drug abuse
• peroral steroid treatment
• cimetidine, anticoagulant or erythromycin treatment at time of inclusion
• not suitable for other reasons

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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257 participants in 2 patient groups, including a placebo group

Metformin

Experimental group

Description:

Metformin 1000mg x 2 daily

Treatment:

Drug: Metformin

placebo

Placebo Comparator group

Description:

Placebo x 2 daily

Treatment:

Drug: Placebo